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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K031774
Device Name HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES
Applicant
Westcon Contact Lens Co., Inc.
611 Eisenhauer St.
Grnad Junction,  CO  81505
Applicant Contact CAROL NOBEL
Correspondent
Westcon Contact Lens Co., Inc.
611 Eisenhauer St.
Grnad Junction,  CO  81505
Correspondent Contact CAROL NOBEL
Regulation Number886.5925
Classification Product Code
LPL  
Date Received06/09/2003
Decision Date 02/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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